Zoledronic Acid in Acute Spinal Cord Injury
Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture prevention and the associated morbidity of bed rest and further secondary complications. Intravenous (IV) zoledronic acid (ZA) is an FDA-approved drug that has been shown to be more effective than other agents in reducing bone mass resorption and leg fractures in post-menopausal women, but has not been studied in patients with acute SCI. This will be a randomized, double-blind, placebo-controlled trial of IV ZA to prevent bone loss early after SCI. Up to 48 subjects will be randomized to receive a one-time dose of 5 mg of IV ZA versus placebo within 21 days of an SCI.
Complete Traumatic Spinal Cord Injury
Drug: Zoledronic acid
Drug: normal saline 0.9%
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Zoledronic Acid to Prevent Bone Loss After Acute Spinal Cord Injury|
- change in bone mineral density [ Time Frame: one year ] [ Designated as safety issue: No ]
Change in bone mineral density (BMD) assessed by dual energy X-ray absorptiometry (DXA) at baseline, 4 months, and 12 months post-injury.
This will compare BMD at the hip, distal femur and proximal tibia.
- Biomarkers of bone formation and resorption [ Time Frame: Baseline, 1 month, 4 month, and 12 months ] [ Designated as safety issue: No ]
Collection of blood biomarkers of bone formation and resorption at selected time intervals within the first 12 months post-injury.
This will observe the timing of metabolic indexes of bone formation and resorption, and of pro-osteoclastogenic factors promoting bone resorption.
- safety and tolerability of zoledronic acid [ Time Frame: one year ] [ Designated as safety issue: Yes ]Assessment of the safety and tolerability of zoledronic acid in the acute spinal cord injury population. This will be done by examination reportable adverse events including fevers, flu-like symptoms, GI upset as measures of safety and report of patient's willingness to have participate in physical therapy in the first week after receiving medication as a measure of tolerability
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: Zoledronic Acid 5 mg IV infusion
Single infusion of 5 mg intravenous zoledronic acid given within 21 days of acute traumatic spinal cord injury.
Drug: Zoledronic acid
5 mg zoledronic acid infused intravenously over two hours (2.5mg per hour), given only once, within 21 days of acute traumatic spinal cord injury.
Other Name: Reclast
Placebo Comparator: normal saline 0.9%
Infusion of normal saline of equivalent volume to reconstituted zoledronic acid, given only once and run over 2 hours, to occur within 21 days of acute traumatic spinal cord injury.
Drug: normal saline 0.9%
Infusion of equivalent volume of 0.9% normal saline to that of the reconstituted zoledronic acid, given only once over two hours, occurring within 21 days of acute traumatic spinal cord injury
Maintenance of bone mass following spinal cord injury (SCI) is essential to fracture prevention and the associated morbidity of bed rest and further secondary complications. Intravenous (IV) zoledronic acid (ZA) has been shown to be more effective than other agents in reducing bone mass resorption and fracture of the legs in post-menopausal women, but has not been studied in acute spinal cord injury. Two previous studies of ZA in persons with subacute SCI, while promising, were inconclusive. As stated in the long range plan of the National Institute on Disability and Rehabilitation Research (NIDRR), one goal in the area of health and function is to "focus on the onset of new conditions…exacerbation of existing conditions, or the development of coexisting conditions." This study is intended to demonstrate reduction in loss of bone mass at the hip and knee regions in acute SCI in a rigorous study of sufficient size to determine effectiveness of our intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642901
|Contact: Christina V Oleson, MDfirstname.lastname@example.org|
|Contact: Ralph J Marino, MDemail@example.com|
|United States, Pennsylvania|
|Thomas Jefferson University and Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Marilyn P Owens, RN, BSN 215-955-6579 firstname.lastname@example.org|
|Contact: Brittany D Hayes, BS 215-955-6579 email@example.com|
|Principal Investigator: Christina V Oleson, MD|
|Sub-Investigator: Ralph J Marino, MD|
|Principal Investigator:||Christina V Oleson, MD||Thomas Jefferson University|